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February 26, 2014
07:46 EDTIPXL, AVNRAvanir likely win patent case against Impax, says Jefferies
After reviewing court transcripts, Jefferies believes Avanir (AVNR) is likely to win its Nuedexta patent trial against Impax (IPXL). The firm says that while the stock is may rally on the patent win, it sees limited upside and keeps a Hold rating on Avanir. Jefferies notes that its $4 price target already assumes full credit for the Nuedexta patent.
News For AVNR;IPXL From The Last 14 Days
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November 24, 2015
09:05 EDTIPXLImpax receives FDA approval for generic version of dutasteride capsules
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November 16, 2015
08:07 EDTAVNRConcert Pharmaceuticals achieves $2M milestone from Avanir
Concert Pharmaceuticals (CNCE) announced that it has achieved a $2M milestone under its development and license agreement with Avanir Pharmaceuticals (AVNR) for the progression of the clinical development of AVP-786. The milestone is a result of Avanir initiating dosing of patients in a Phase 3 clinical trial with AVP-786 for the treatment of agitation in patients with Alzheimer's disease. The collaboration agreement between Concert and Avanir provides Avanir with worldwide rights to develop and commercialize AVP-786 and other deuterium-modified dextromethorphan (d-DM) compounds. Under the agreement, Concert is eligible to receive additional milestone payments based upon achievement of certain predefined regulatory and commercial targets. Avanir will continue to have overall responsibility for research, development and commercialization of d-DM compounds, including AVP-786, and Concert is eligible to receive tiered royalties on worldwide sales of any products containing d-DM. The milestone announced today is the third development milestone Concert has earned under this agreement.
08:05 EDTAVNRAvanir initiates Phase III trial of AVP-786
Avanir announced initiation of enrollment into a phase III clinical trial evaluating AVP-786 for the treatment of agitation in patients with Alzheimer's disease. This is the first of two placebo-controlled phase III trials in the company's TRIAD program. Avanir Pharmaceuticals recently received Fast Track designation from the FDA for the development of AVP-786 for this indication. The phase III studies are multicenter, randomized, double-blind, placebo-controlled trials that will evaluate two doses of AVP-786 versus placebo over a period of 12-weeks. Endpoints in these studies will include the Cohen Mansfield Agitation Inventory, the agitation/aggression domain of the Neuropsychiatry Inventory (NPI), other domains of the NPI, measures of global clinical change, and measures of caregiver burden and quality of life. Standard safety measurements will also be performed. TRIAD-1 is expected to enroll approximately 380 patients in 60 centers in the United States. TRIAD-2 is expected to enroll approximately 325 patients in 50 centers in the U.S. and will begin later in 2015. In addition to these two U.S. based trials, there will be additional global trials that will be conducted as part of the TRIAD program. Avanir has also initiated a phase II study to assess the efficacy, safety and tolerability of AVP-786 for the treatment of symptoms associated with residual schizophrenia. This study is expected to enroll approximately 120 patients in the U.S. Additionally, Avanir is currently enrolling patients in a phase II study of AVP-786 for the adjunctive treatment of major depressive disorder. This study began in 2014 and is expected to complete enrollment in 2015.
07:16 EDTIPXLHayman Capital gives quarterly update on stakes
NEW STAKES: Impax (IPXL), CF Industries (CF), GW Pharmaceuticals (GWPH), ProNAi Therapeutics (DNAI). INCREASED STAKES: BioMarin (BMRN), NMI Holdings (NMIH), Vertex (VRTX), Endo (ENDP). DECREASED STAKES: Mylan (MYL). LIQUIDATED STAKES: Perrigo (PRGO), Oasis Petroleum (OAS), Whiting Petroleum (WLL), Newfield Exploration (NFX), SM Energy (SM).

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